NCT04568512

Brief Summary

DNA methylation biomarker for diagnosis of cholangiocarcinoma in patients with bile duct stricture has high sensitivity and specificity compared with cytology from the brush specimens

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

4 years

First QC Date

September 23, 2020

Last Update Submit

September 23, 2020

Conditions

CholangiocarcinomaBiliary StrictureDNA MethylationBrush Cytology

Outcome Measures

Primary Outcomes (1)

  • The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture

    Methylation index of biliary brush samples were analyzed.

    2 weeks

Secondary Outcomes (2)

  • Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma

    2 weeks

  • To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples

    2 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology

Diagnostic Test: Control

Cholangiocarcinoma

ACTIVE COMPARATOR

Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology

Diagnostic Test: Cholangiocarcinoma

Interventions

ControlDIAGNOSTIC_TEST

Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology

Control
CholangiocarcinomaDIAGNOSTIC_TEST

Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology

Cholangiocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18 year old
  • Patients had biliary stricture from cholangiocarcinoma and benign stricture

You may not qualify if:

  • Pregnancy
  • Patient had other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Prachayakul V, Rugivarodom M, Nopjaroonsri P, Cheirsilpa K, Chang A, Kamolhan T, Boonyaarunnate T, Thuwajit C, Thuwajit P. Diagnostic power of DNA methylation markers suggestive of cholangiocarcinoma in ERCP-based brush cytology. Gastrointest Endosc. 2022 Jan;95(1):123-130.e1. doi: 10.1016/j.gie.2021.07.005. Epub 2021 Jul 12.

    PMID: 34265285DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Varayu Prachayakul

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 29, 2020

Study Start

January 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)